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Completed

NCT Number: NCT03845309

Nutritional Interventions in Chronic Heart Failure

This study recruited patients diagnosed with heart failure by cardiologists and cardiac outpatients whose cardiac functions were graded from 1 to 4 according to the New York Heart Association as the study participants. The participants were provided active nutrition intervention including diet optimization,specific recommendations and nutritional supplement prescriptions in cases in which nutritional goals were not reached.In addition, this study offered advice by referencing lifestyle change advice provided by the American Heart Association for patients with heart failure.

The Mini Nutritional Assessment Short-Form was used to assess malnutrition indicator values. The participant water, nutrient (i.e., carbohydrates, protein, and fat), and calorie intake data were collected using their recollection of their dietary intake and food intake frequency over a 24-hour dietary recall. The amount of fluid and sodium administered was provided according to the cardiac function grades indicated by the New York Heart Association.In addition, dietary assessments and nutritional advice were offered on the basis of the patients' conditions (i.e., age, activity, and comorbidity).

Finally, instrumental activities of daily living, EQ-5D (an instrument for measuring quality of life), grip performance, and 6-minute walk test data were utilized to analyze the changes in the participants before and after intervention, identifying the correlation between using nutrition education as an intervention measure and improvement in the participants' nutritional status, quality of life, and self-care behavior.

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Key information

Conditions

Chronic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Nutrition

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal Medicine, National Taiwan Univeristy Hospital Yun-Lin branch

Douliu, Yunlin County, 640, Taiwan

About this study

Malnutrition may be caused by decreased nutrient intake or absorption, inflammation, or other disease-related mechanisms. Malnutrition resulting from disease or injury may be caused by decreased food intake or varying degrees of acute or chronic inflammation, which alters body composit ion and prompts a decline in biological functions. The effects of decreased food intake induced by an inflammatory reaction are related to the malnourishment resulted from anorexia, changes in metabolism, increased resting energy expenditure, and increased muscle catabolism. Changes in body composition are characterized by a decrease in any muscle mass marker (excluding fat mass, muscle mass index, or body cell mass). Therefore, malnutrition is associated with clinical results of clinical malfunction.

The primary objectives of heart failure treatment include preventing the need for hospitalization, increasing the survival rate, and improving health status. Patient symptoms, bodily functions, and health status are also referred to as health-related quality of life (HRQoL). The EuroQol-5D (EQ-5D) is used to assess the quality of life of patients undergoing cardiac rehabilitation. This assessment uses 5 aspects, namely mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, to assess patient health status.

Cardiopulmonary exercise testing (CPET) is the gold standard method for evaluating the motor ability of patients with chronic heart failure (CHF), yet is not extensively used. A more commonly used and simpler method is the 6-minute walk test, which measures the distance traveled by walking for 6 minutes. Changes in this value correlate to quality of life. This test is used to investigate the ability to perform daily activities and intensity of exercise in patients with mild to moderate CHF.

Muscle strength is a key indicator for assessing patients with sarcopenia because decreased muscle strength is considered a crucial element in diagnosing muscle reduction. For circumstances in which muscle mass is difficult to assess, muscle strength, such as handgrip strength, can serve as a standard assessment of muscle functions.

Exercise training is considered a valid method for stabilizing patients with heart failure. One study reported that the self-management intervention of a patient with heart failure notably decreased the occurrence of hospitalization and hospital readmission related to heart failure as well as all-cause mortality.

The present study determines the effectiveness of nutrition intervention in routine medical treatment for improving the nutrition and quality of care among patients with heart failure.

This study does not involve drugs, medical technology, or medical equipment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with CHF by a cardiologist. Clinical patients with the functional classification of NYHA FcI-NYHA FcⅣ according to the New York Heart Association (NYHA).
  • Adults aged 20 years or older who are conscious, have normal cognitive function, can walk without assistance, and do not require breathing aids. Additionally, participants must be able to answer questionnaires in Mandarin Chinese or Taiwanese, either orally or in writing.
  • Patients who have agreed to participate in the study by completing a consent form.

Exclusion criteria

  • Patients with an expected survival period of less than 6 months because of a disease not related to CHF
  • Long-term bed-bound patients
  • Patients with no potential for rehabilitation because of decline in functions of neural or musculoskeletal systems
  • Patients with severe disorders of consciousness or cognitive disorders or those with mental illness
  • Patients who require breathing aids for an extended period of time
  • Patients with end-stage severe CHF who have been diagnosed by doctors as unable to recover within a short period
  • Patients who are scheduled to undergo coronary artery bypass surgery or a heart valve surgery within 1 month
  • Patients who are on hemodialysis or are awaiting a kidney transplant
  • Patients with severe pulmonary diseases who require long-term home oxygen therapy
  • Patients who themselves decline to participate or who have a family member who objects to their participation.

Treatment and study plan

Self-Care Behavior

Behavioral

Limitations on liquid and sodium intake will be established in accordance with the NYHA functional classification, and patients will be provided with dietary assessments and nutrition advice according to personal characteristics such as age, physical activity level, and comorbidities. Additionally, suggestions on lifestyle changes were provided by referring to the advice for patients with heart failure from the American Heart Association.

Primary outcomes

  1. Mini Nutritional Assessment Short-Form

    Time frame: Change from Baseline Mini Nutritional Assessment Short-Form on months 0, 3 at 6 months(Do higher values represent a better outcome).

    Assess malnutrition indicator values. Nutrition status evaluated by the MNA correlates with energy and nutrient intakes as well as anthropometrics, hematologic, and biological nutrition parameters.

    MNA has 4 sections: anthropometrics (BMI, weight loss, arm and calf circumference), general assessment (lifestyle, medication, mobility, presence of depression or dementia), dietary assessment (number of meals, food and fluid intake, autonomy of feeding), and subjective assessment (self-perception of health and nutrition).

    The maximum score for the MNA-SF is 14, with scores ≥12 indicating satisfactory nutrition status and ≤11 indicating a risk of malnutrition.

  2. Instrumental Activities of Daily Living

    Time frame: Change from Baseline Instrumental Activities of Daily Living on months 0, 3 at 6 months.

    Instrumental Activities of Daily Living Heath-related quality of life. IADL Scale was developed to assess more complex activities (termed "instrumental activities of daily living") necessary for functioning in community settings (e.g., shopping, cooking, managing finances). The capacity to handle these complex functions normally is lost before basic "activities of daily living" (e.g., eating, bathing, toileting) which are measured by ADL scales. Therefore, assessing IADLS may identify incipient decline in older adults or other individuals who are otherwise capable and healthy.

    It contains 8 items that are rated with a summary score from 0 (low functioning) to 8 (high functioning).

    This scale can be administered through an interview or by a written questionnaire.

  3. EuroQol-5D

    Time frame: Change from Baseline EuroQol-5D on months 0, 3 at 6 months(Do higher values represent a better outcome).

    Assess the quality of life of patients undergoing cardiac rehabilitation. the generic EuroQol fivedimensional questionnaire (EQ-5D) instrument are commonly referred to as value sets; an important distinction lies in whether the valuations are elicited from individuals with experience of the health state (experience-based values) or from individuals from the general population to whom the health states are described (hypothetical values).

    • 100 means the best health you can imagine.
    • 0 means the worst health you can imagine.

  4. Handgrip strength

    Time frame: Change from Baseline Handgrip strength on months 0, 3 at 6 months.

    Assessment of muscle functions. Measured by dynamometer, before and after intervention. We will compare the statistical properties of between baseline and after 0, 3 at 6 months intervention.

  5. 6-Minute walk test

    Time frame: Change from Baseline 6-Minute walk test on months 0, 3 at 6 months(Do higher values represent a better outcome).

    Changes in this value correlate to quality of life

Secondary outcomes

  1. Energy intake

    Time frame: Change from Baseline Energy intake on months 0, 3 at 6 months.

    Energy intake (Kcal/day)will be assessed by dietary survey on 24-hour recall.

  2. Carbohydrate intake

    Time frame: Change from Baseline Carbohydrate intake on months 0, 3 at 6 months.

    Carbohydrate intake (g / day) will be assessed by dietary survey on 24-hour recall.

  3. Protein intake

    Time frame: Change from Baseline Protein intake on months 0, 3 at 6 months.

    Protein intake (g / day) will be assessed by dietary survey on 24-hour recall.

  4. Fat intake

    Time frame: Change from Baseline Fat intake on months 0, 3 at 6 months.

    Fat intake (g / day) will be assessed by dietary survey on 24-hour recall.

  5. Sodium intake

    Time frame: Change from Baseline Sodium intake on months 0, 3 at 6 months.

    Sodium intake (gm / day) will be evaluated by dietary survey on 24-hour recall.

  6. Water intake

    Time frame: Change from Baseline Water intake on months 0, 3 at 6 months.

    Water intake (ml / day) will be evaluated by dietary survey on 24-hour recall.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

The Effect of Using Nutrition Education as an Intervention Measure on Elevating the Nutritional Status, Quality of Life, and Self-Care Behavior of Patients With Chronic Heart Failure

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2019
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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